Great Basin Bordetella Direct Test

Qualitative detection of Bordetella Pertussis

RELEVANCE

B. pertussis is the causative agent of Pertussis, also known as “Whooping Cough.” The CDC reported over 20,000 cases of Pertussis in 2015 in the US 1.  Despite the availability of a Pertussis vaccine, immunity is waning, particularly in adolescent and young adult populations. Infants are particularly vulnerable to the disease.

While large molecular respiratory panels are available, the distinctive clinical presentation of B. pertussis demands stand-alone, STAT testing.

Currently, the most common route for Bordetella testing is to send specimens to a state or reference lab which, in the case of a reference lab, can be prohibitively expensive and cause several days – even weeks – delay in obtaining a result, during which time the patient may not be receiving appropriate treatment. Further, specimen collection methods vary by clinical sites, necessitating an assay capable of accepting a broad range of media types.

INTENDED USE

The Great Basin Bordetella Direct Testis a qualitative in vitro diagnostic test for the detection of Bordetella pertussis DNA from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis. It identifies the insertion sequence IS481 of Bordetella Pertussis genome.

Negative results for the Great Basin Bordetella Direct Test do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Great BasinBordetella Direct Test should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in the diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

This in vitro diagnostic test is configured for use on Great Basin Analyser with Great Basin Bordetella Direct Test Cartridge Kit.

FEATURES AND BENEFITS

Faster Clinical Decision Making and Improved Patient Outcomes

  • Produces definitive results without the use of a large respiratory panel
  • Easy-to-use sample-to-result solution delivers more diagnostic data per sample than low-plex technologies
  • High sensitivity and specificity
  • Validated with several media types (VTM/UTM, ESwabs, Liquid Stuart, saline, Tris EDTA, and other elution buffers)
  • Faster turnaround time (<2 hrs)
  • Prompt treatment and public health reporting and facilitating outbreak readiness in your lab

Increased Lab Productivity

  • No additional hand-on-steps required
  • Compatible with virtually any nasopharyngeal specimen collection protocol

Increasing Laboratory Effectiveness

  • STAT testing for targeted analytes
  • Sample-to-result with less than <2 mins hands-on-time per sample
  • Small instrument footprint

 

WORKFLOW

SPECIFICATIONS

AttributeValue
Analytical Sensitivity 

2.4 x 103/span> CFU/mL

Analytical Reactivity

Able to detect 100% of all 11 B. pertussis strains

Analytical Specificity

No cross-reactivity with 90 other microorganisms tested

Clinical Sensitivity

92.5%

Clinical Specificity

99.6%

Reproducibility 100%
Sample Type(s) Nasopharyngeal swabs

ORDERING INFORMATION

ProductPack SizeItem Number
Great Basin Bordetella Direct Test 10 300782

References

  1. CDC: 2015 Final Pertussis Surveillance Report